Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RSV Vaccine formulation 1 · 1 trial · 1 indication
Assessed solicited general AEs were fatigue, gastrointestinal symptoms \[nausea, vomiting, diarrhea and/or abdominal pain\], fever and headache. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.Grade 2 symptoms = occurrence of symptoms discomforting enough to interfere with daily activities. Grade 3 symptoms = symptoms that prevented normal activities. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Grade 2 Fever was defined as oral temperature above (\>) 38.5 degrees Celsius (°C) to less than or equal to (≤) 39.5°C. Grade 3 Fever was defined as oral temperature \> 39.5°C. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAEs = SAEs assessed by the investigator as related to the vaccination. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
RSV-A is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value greater than or equal to (≥) 8 ED60 (Estimated Dilution 60). This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off ≥ 9.6 µg/mL. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off ≥ 9.6 µg/mL. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
| Arm | Type | Description |
|---|---|---|
| GSK3003891A vaccine formulation 1 Group | EXPERIMENTAL | Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0. |
| GSK3003891A vaccine formulation 2 Group | EXPERIMENTAL | Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| GSK3003891A vaccine formulation 3 Group | EXPERIMENTAL | Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| Control Group | PLACEBO_COMPARATOR | Subjects in this group received a single placebo injection at Day 0. |
| Name | Type | Description |
|---|---|---|
| RSV Vaccine (GSK3003891A) formulation 1 | BIOLOGICAL | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
| RSV Vaccine (GSK3003891A) formulation 2 | BIOLOGICAL | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
| RSV Vaccine (GSK3003891A) formulation 3 | BIOLOGICAL | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
| Placebo (Formulation buffer S9b) | DRUG | A single dose of placebo is administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performance of any study specific procedure. * Non-pregnant female between, and including, 18 and 45 years...
RSV Vaccine formulation 1 is an investigational vaccine being developed for the prevention of Respiratory Syncytial Virus (RSV) infections. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The vaccine is being studied in healthy adult women to evaluate its immune response and safety.
RSV Vaccine formulation 1 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy adult women for the prevention of Respiratory Syncytial Virus infections.
RSV Vaccine formulation 1 is currently in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA or other regulatory agencies. The Phase 2 trial has been completed, and the vaccine remains under investigation for the prevention of Respiratory Syncytial Virus infections.
RSV Vaccine formulation 1 has one completed Phase 2 clinical trial registered as NCT02956837. This randomized, double-blind, placebo-controlled study enrolled 406 healthy adult women across Belgium, Estonia, France, and Germany. The trial aimed to rank different dosages of the vaccine antigen based on immune response and safety.
RSV Vaccine formulation 1 is designed to elicit an immune response against Respiratory Syncytial Virus (RSV) by presenting viral antigens to the immune system. This is intended to generate protective antibodies that can neutralize the virus and prevent infection. The vaccine is being studied in healthy adult women to assess its immunogenicity and safety profile.
Yes, RSV Vaccine formulation 1 is also known as GSK3003891A, as referenced in the clinical trial NCT02956837. The trial title describes GSK's investigational RSV vaccine as GSK3003891A, which is the same vaccine candidate being evaluated for the prevention of Respiratory Syncytial Virus infections in healthy adult women.